Admin
Maintains people, users and access for the quality workspace.
Can
- Manage People, Users
- View Inspections, Nonconformances, corrective actions, Audits, controlled documents
- Pharmaceuticals QMS
- Roles and permissions
Who can do what in Pharmaceuticals QMS
Give quality work to named owners and keep review decisions with the responsible people.
Who can do what
| Role | Inspections | Nonconformances | Corrective Actions | Out Of Specification | Environmental Monitoring | Audits | Documents and Training |
|---|---|---|---|---|---|---|---|
| Admin | Edit | View | Edit | Edit | Edit | Edit | Edit |
| Inspector | Edit | Edit | Edit | Edit | Edit | View | View |
| Quality Reviewer | View | Edit | Approve | View | View | — | — |
| Corrective Action Owner | View | View | Edit | View | — | — | — |
| Auditor | View | — | View | View | View | Edit | View |
| Document Controller | View | — | View | View | View | Edit | Edit |
| Laboratory Reviewer | View | View | View | Edit | — | — | — |
| Manufacturing Reviewer | View | View | View | Edit | — | — | — |
Each role in detail
Inspector
Runs assigned inspections and records linked checks and specialty quality cases.
Can
- Manage Inspections, inspection checks, out of specification cases, environmental samples
- View People, Nonconformances
Starts on: Inspection queue
Quality Reviewer
Reviews inspection evidence and verifies corrective action effectiveness independently of the owner.
Can
- Manage Nonconformances
- View Inspections, inspection checks, corrective actions, environmental samples, out of specification cases
Reviews and approves
- Approve corrective actions
Starts on: Inspection queue
Corrective Action Owner
Documents root cause, action and completion for assigned correction.
Can
- Manage corrective actions
- View Nonconformances, Inspections, inspection checks
Starts on: Corrective action work
Auditor
Plans audits and records findings with assigned owners and due dates.
Can
- Manage Audits, audit findings
- View People, controlled documents, training acknowledgments
Starts on: Audit findings due
Document Controller
Maintains controlled document versions and follows acknowledgments.
Can
- Manage controlled documents, training acknowledgments
- View People, Audits, audit findings
Starts on: Document review queue
Laboratory Reviewer
Reviews out of specification cases after an inspector submits them.
Can
- Manage out of specification cases
- View Inspections, inspection checks
Starts on: Out of specification review
Manufacturing Reviewer
Reviews out of specification cases after laboratory review.
Can
- Manage out of specification cases
- View Inspections, inspection checks
Starts on: Out of specification review
Set up Pharmaceuticals QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.